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The RoyalGuard Surgical Gown, i600, Breathable is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The RoyalGuard Surgical Gown, i600, Breathable has been tested as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-S1) consists of a tri-laminate fabric Breathable Viral Barrier (BVB) including an outer and inner layer of spunbond polyolefin fabric with a middle layer of breathable monolithic film in the gown front body and gown sleeves. The gown sleeves critical zones also consist of an additional layer of Film Reinforcement Bi-laminate material, including a layer of spunbond and a layer of film. The gown back panels are comprised of a single layer of SMS (polyolefin nonwoven). The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-S1) is provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight regular sizes and two special sizes (A-frame) available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, A-frame L-XLONG, Aframe XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures. The RoyalGuard Surgical Gown, i600, Breathable (i90-61xx-51) has been tested according to AAMI PB70:2012 and met the AAMI Level 4 liquid barrier performance requirements. It is constructed with or without thumb-hooks in cuffs. The addition of thumb-hooks does not impact the performance of the gown in accordance with AAMI PB70 requirement.

This document describes the premarket notification (510(k)) for the RoyalGuard Surgical Gown, i600, Breathable. The core of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

The acceptance criteria and device performance are based on physical and barrier performance testing, not an AI/human reader study for diagnostic accuracy. Therefore, several of the requested sections related to AI performance, expert consensus, and MRMC studies are not applicable.

Here's the information as it applies to this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" primarily refer to adherence to established national and international standards for surgical gowns, and "device performance" refers to the results of testing against those standards.

2. Sample size used for the test set and data provenance:

• Sample Size: The document does not specify exact sample sizes (number of gowns or material samples) for each test. Medical device testing is typically performed on a statistically relevant number of samples to ensure representativeness and consistency.
• Data Provenance: The testing was conducted by GRI Medical & Electrical Technology Co., Ltd. (the applicant/manufacturer). The nature of the testing (physical and barrier performance) strongly suggests these were prospective lab tests performed on manufactured samples of the RoyalGuard Surgical Gown. The country of origin for the data generation would be China, where the manufacturer is located, given the contact information provided (JiaXing, ZheJiang, China).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a physical and biological performance study for a surgical gown, not an AI/diagnostic imaging study. Ground truth is established by standardized test methods (e.g., AAMI PB70, ASTM, ISO standards) and objective measurements performed in a lab setting, not by expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set:

• Not Applicable. As this is not a study involving human interpretation or subjective assessment, adjudication methods are not relevant. Test results are quantitative measurements against established pass/fail criteria from recognized standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI/algorithm device.

7. The type of ground truth used:

• The "ground truth" for this device is based on objective measurements from performance standards and laboratory testing. For example:
  • AAMI PB70:2012 (Liquid Barrier Performance): This standard defines specific tests (e.g., ASTM F1671 for viral penetration, AATCC 42 for impact penetration) with quantitative pass/fail criteria to classify gown barrier levels. The ground truth is the measured resistance to fluid and viral penetration.
  • ISO 10993 (Biocompatibility): This set of standards uses in vitro and in vivo tests to assess materials for cytotoxicity, sensitization, and irritation. The ground truth is the observed biological response (or lack thereof) to the material.
  • 16 CFR Part 1610 (Flammability): This standard defines methods to test flammability and classifies materials based on burn rate. The ground truth is the measured flammability.
  • ASTM Physical Properties: These standards define methods for measuring material properties like basis weight, tensile strength, tear strength, and seam strength. The ground truth is the measured physical property.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured product tested against performance standards.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

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